It all started when we came to update our recommendations. From time to time we come back and make sure that the products we’ve recommended are still performing the way they were when we first recommended them. Of course, int the past manufacturers have been known to start cutting corners in order to increase their margins, and the quality of products can change over time. As such, we like to perform periodic reviews to make sure everyone is still happy with their products.
We were really surprised to find literally all of our recommendations delisted from Amazon. What was even more surprising is that when we tried to find the various micro needling devices we had recommended, most of them were gone. When before there were literally dozens or products to compare, now there were only a handful left. The products we had recommended before had absolutely stellar reviews, often numbering in the thousands. Now, we’re left with products that have barely two dozen reviews each. We still stand by our recommendations, but wanted to take a moment to explain to our readers why this is happening.
Around the same time we wrote our original post there were some significant changes to micro needling regulations that resulted in the original derma pen, as well as micro needling devices more broadly, being pulled from the US market. The short story is that they are awaiting approval. The long story involves the FDA classification and approval process. If you’re interested and want to know exactly how this affects the safety and efficacy of micro needling devices, keep reading.
FDA Position on Micro Needling Devices
First a bit about the FDA process. The FDA has a classification system that determines how and when product can reach the market. We aren’t sure about other companies, but we know from correspondence released between Derma Pen LLC and the FDA that the Derma Pen LLC micro needling device was released to market by the company as a Class 1 medical device exempt from Premarket Notification and marketing clearance from the FDA.
The company listed their device “under 21 CFR § 878.4820, powered dermabrasion devices “have abrasion substrates which are brushes, rasps and burrs that are intended to abrade and remove layers of skin via shear force.” The FDA did not agree with this classification on the grounds that “the Dermapen and similar micro-needling devices use needles to penetrate the skin rather than shearing away layers of skin” and as such, is not exempt from premarket notification.
So what does this mean? It means that Derma Pen has agreed to stop selling it’s micro needling device in the United States and does not appear to be actively pursuing approval. Likewise, the company has also stated that there are about 10 other distributors of micro needling devices in the United States, 8 of which had classified their devices as Class 1 exempt as well, which they suspect means that those companies will also receive warning letters.
What Does FDA Approval Mean for Micro Needling?
The sale of micro needling devices in the United States falls broadly under the regulatory auspices of the FDA. It should also be noted that FDA approval is not strictly required for things like cosmetics and dietary supplements provided that the manufacturer doesn’t make any health related claims. Given that it’s a costly procedure, most manufacturers elect to market their products as cosmetics rather than drugs.
Thus, even without FDA approval many products can still be commercially distributed. The situation is a little different when it comes to devices.
The classification of a device determines whether it can be sold at all, and “depends on various factors including: the device itself, its purpose, claims you are making, and the risk posed by the device.” At present (December 2015) no micro needling devices are FDA approved. Furthermore, according to the FDA, if the device has been determined to require Premarket Notification then “you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing you to do so.” In order for the FDA to approve a medical device like micro needling devices, “a device’s manufacturer must prove to the FDA that the item is ‘safe and effective’”
In our research we’ve heard (anecdotally – mostly on forums) that the remaining micro needling devices being sold on Amazon US will soon be gone too. As it stands and as far as we know, they are still being sold in Europe through vendors like Amazon UK.